SABCS: Full Response Aids Better Breast CA Survival

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that a complete pathologic response before surgery among early breast cancer patients correlates strongly with improved disease-free survival and improved overall survival at three years.

SAN ANTONIO -- If early-stage breast cancer patients can achieve a pathologically complete response before undergoing surgery it strongly correlates with improved disease-free survival -- and better overall survival -- at three years, researchers reported here.

In the Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO) trial, conducted among more than 200 women, 39% were declared cancer-free following pathologic examination after chemotherapy and surgery -- either mastectomy of breast conserving therapy -- according to Michael Untch, MD, head of the multidisciplinary breast cancer department at the Helios Clinic in Berlin, Germany.

Of those women who had a pathological complete response, 88% achieved disease free survival at the three-year follow-up compared with 73% of those patients who did not achieve a complete response before surgery (P=0.01), Untch reported at the San Antonio Breast Cancer Symposium.

Untch also reported that overall survival was 96% in the group of patients who achieved a pre-surgery pathological complete response compared with an overall survival of 86% among those women who did not have a pathologic complete response before surgery (P=0.025).

"The neoadjuvant combination of trastuzumab for 12 weeks and chemotherapy results in high pathological response rate," Untch wrote in his poster presentation. "However, those patients without a pathological complete response have an increased risk for relapse and death and are therefore candidates for further improvement of anti-HER2 directed post surgical therapy."

"One theme that is emerging from this study and others is that clearly a pathologic complete response is a good prognosis factor," said Steven Isakoff, MD, a medical oncologist at the Gillette Center for Breast Cancer at Massachusetts General Hospital in Boston.

He told MedPage Today that while those who do not achieve a pathologic complete response do not do as well, but among those women who are unable to achieve a complete response with first line therapies, "there are still subgroups that eventually do very well."

The TECHNO study recruited 217 patients, with primary breast cancers that overexpressed HER2 and tumors at least two cm in size, or who had inflammatory breast cancer.

Patients received four cycles of epirubicin 90 mg/m2 once every three weeks preoperatively; cyclophosphamide 600 mg/m2, once every three weeks followed by four cycles of paclitaxel (Taxol) 175 mg/m2 once every three weeks, with trastuzumab 6 mg/kg every three weeks after a loading dose of 8 mg/kg. The chemotherapy was followed by surgery. Trastuzumab was continued after surgery until completion of 12 months of treatment.

Among the TECHNO participants, breast conserving surgery was possible in 138, about 64% of the women, Untch said.

Isakoff remarked that the standard drug regimen used in the U.S. differs in regard to paclitaxel. Instead of a cycle every three weeks, the usual treatment in the U.S. is for weekly paclitaxel treatment.

He suggested that a change in the treatment protocol might show a difference in patients who achieved a pathologic complete response. He said that the 39% achievement rate in the TECHNO study might be considered on the low side of what is generally seen in patients who are eligible for neoadjuvant therapy.

The median age of the women in the TECHNO study was 48.5 years. About 66.2% of the women were diagnosed with clinical stage of cT2. N1 disease was diagnosed in 59.7% of the women, Untch said. At diagnosis all of the women were clinically free of metastases.

Untch reported that 87.9% of the women were diagnosed with invasive ductal breast cancer; 6% were diagnosed with invasive lobular cancer and 1.9% was found to have inflammatory breast cancer.

Median follow-up in the TECHNO study was 41 months.

A cardiac event was reported in eight patients; in six of these patients a decrease was observed in left ventricular ejection factor. Two patients developed clinical congestive heart failure, Untch reported.

Untch had not relationships to disclose.

The German Breast Group is funded by sanofi-aventis, Roche and GlaxoSmithKline.

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